BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H CEMENTLESS STEM SIZE 5 STD

    MDR report key: 5239251 · Received November 20, 2015

    Report

    Report Number
    3005180920-2015-00281
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    October 22, 2015
    Report Date
    February 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 20 JANUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 25 JANUARY 2016, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 12 NOV 2015 IT WAS COMMUNICATED THAT REV. REASON: THIGH PAIN, VISIBLE DUE TO LOOSENING OF THE STEM ON RX. REV. ROUTINE: STEM AND HEAD CHANGED. BATCH REVIEW PERFORMED ON 17 NOVEMBER 2015: LOT 113027: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 DECEMBER 2011. EXPIRATION DATE: 2016-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ON 18 NOV 2015 THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: FEMORAL STEM REVISION 3,5 YEARS AFTER PRIMARY IMPLANT DUE TO FEMORAL ASEPTIC LOOSENING. FROM THE XRAY, LOOSENING IS VISIBLE THOUGH NOT VERY EVIDENT, BUT I CANNOT DISCERN ANY PLAUSIBLE CAUSE FOR THIS OCCURRENCE THAT CAN BE RELATED TO A CLINICAL MISTAKE. APPARENTLY, LOOSENING STARTED IN THE PROXIMAL REGION AND IT IS MORE EVIDENT PROXIMALLY. A MALE PATIENT, WITH DORR TYPE A FEMUR, STRONG AND THICK CORTICAL BONE IN THE CANAL IS POSSIBLY MORE LIKELY TO GET THIS KIND OF COMPLICATION, WHICH IS RARE BUT DESCRIBED IN LITERATURE. ON 19 NOV 2015 IT WAS CONFIRMED THAT THE ITEM WILL NOT BE AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    REVISION BECAUSE OF PAINFULLY STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769646 QUADRA H CEMENTLESS STEM SIZE 5 STD 01.12.025 JDI MEDACTA INTERNATIONAL SA 113027

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention